Monday, December 19, 2011

FDA warns Lap-Band doctors to stop misleading consumers

The U.S. Food and Drug Administration (FDA) is warnings several medical centers to stop their misleading advertising for the Lap-Band weight loss device.

The Lap-Band is a silicone gastric band that a surgeon places around the stomach to create a small pouch near the top, limiting the amount a person can eat at one time and making them feel fuller sooner.

There are currently two gastric bands approved by the FDA, the Lap-Band by Allergan Inc. and Realize Adjustable Gastric Band by Ethicon Endo-Surgery Inc.

This month, the FDA sent warning letters to the marketing company 1-800-GET-THIN LLC and the eight California surgical centers San Diego Ambulatory Surgery Center, LLC, Bakersfield Surgery Institute Inc., Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons LLC, Valencia Ambulatory Center LLC and Cosmopolitan Plastic & Reconstructive Surgery telling them to stop their misleading advertising of the Lap-Band medical device.

According to the FDA, their billboard and pamphlet advertising failed to provide risk information, including warnings, precautions, possible side effects and contraindications as required by the Federal Food, Drug and Cosmetic Act. Where they did communicate risks, the font size of the text was too small for consumers to read.

“FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health in a Consumer Update. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

Gastric banding is only for patients who fit certain obesity criteria. The FDA has approved Lap-Band for morbidly obese patients with a Body Mass Index (BMI) of at least 40, or a BMI of 30-40 in conjunction with obesity related conditions such as high blood pressure, heart disease, diabetes or sleep apnea. The Realize Adjustable Gastric Band is FDA approved for patients with a BMI of 40, or of 35 in conjunction with other obesity related conditions.

Gastric banding is not a cure for obesity. For successful weight loss, patients must make major, long-term dietary changes in addition to gastric banding.

There are risks of serious complications with gastric banding. In addition to surgical risks, people with a gastric band may suffer:

gastroesophageal reflux disease (GERD)
erosion of the band through the stomach wall
stretching of the esophagus or new stomach pouch
leaking of the gastric band
migration of the gastric band
abdominal pain
difficulty swallowing

The Los Angeles Times reports that four patients died following procedures at surgical centers affiliated with the ad campaign, and a fifth death is under investigation.

A spokesperson for Allergan, maker of the Lap-Band, told Medscape Medical News that it had no financial ties to 1-800-Get-Thin and has no control how its customers, the surgeons, promote the device.

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